510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K033402Substantially Equivalent

Portable Sleep Data Recorder (Psdr)

Pro-Tech Services, Inc., Mukilteo WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K033402 is the FDA 510(k) clearance record for PORTABLE SLEEP DATA RECORDER (PSDR), a class II device, cleared for Pro-Tech Services, Inc. on under FDA product code MNR (Ventilatory Effort Recorder). FDA records list 7 510(k) clearances for Pro-Tech Services, Inc., from to . As of , FDA records show no recalls naming K033402.

Clearance record

Decision date
Received
(250 days to decision)
Product code
MNR Ventilatory Effort Recorder
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Pro-Tech Services, Inc. 4338 Harbour Pt.e Blvd. SW, Mukilteo WA
510(k) summary
Statement
Third party review
Yes

Clearances, product code MNR

Trailing 12 months
6 clearances under product code MNR in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MNR, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20260
September 20261
October 20260